SkinBioTherapeutics plc (AIM: SBTX) announced on 11/7/18 positive data from the first two elements of its human study which focus on skin irritancy and moisturisation potential.
As previously announced on 19 September 2018, the third, main element of the human study will commence later this month (November). This will comprise 120 volunteers with self-assessed ‘dry skin’, and is designed to analyse the longer term moisturisation effects and impact on skin barrier function of the SkinBiotix technology in more depth.
The elements of the study that were carried out during September and October 2018 were as follows:
Skin Irritation Study
24-72 hours test - involved applying a cream containing SkinBiotix® to 30 healthy subjects in a series of five doses of increasing concentration. The area of skin treated was then covered to drive absorption of the cream into the skin. At 24, 48 and 72 hours following application, subjects were assessed for any signs of irritation. There were no instances of irritation in any of the subjects - even at 20X the standard use dose of SkinBiotix.
Repetitive, longer term test - involved repeated application of the cream at five doses to the skin of 31 healthy subjects. The product was in contact with the skin for 12 days, using an exaggerated exposure method to provide a more rigorous test of skin tolerance. The volunteers were regularly monitored for signs of irritation for up to 15 days following the initial application. While one volunteer experienced irritation in response to the cream (which occasionally happens in tests using prolonged exposure under exaggerated test conditions), no irritation was observed in the remaining 30 volunteers, even at concentrations of SkinBiotix well above that of therapeutic use (up to 20X the standard dose).
Moisturisation Potential Study
The moisturisation effect of the SkinBiotix technology was tested in a 12 hour study - an industry standard test - using 21 healthy subjects. In this study, the cream containing SkinBiotix was applied to an area of skin and the moisture content of the skin was measured for up to 12 hours. The moisturising effect of the cream without the technology was also measured as a control for comparison. As in-house laboratory tests have indicated that SkinBiotix requires at least 24 hours to produce its effects, no difference was anticipated when compared against the control.
The cream containing SkinBiotix provided good moisturisation which was generally higher than that provided by the control cream but the difference was not significant.
No irritation was observed in this study in any volunteer.
Dr Cath O'Neill, CEO, commented, “Demonstrating that SkinBiotix is a safe technology is a major milestone for the Company and, as with many cosmetics, allows for commercialisation of a product. The irritation study results validate the safety element of our technology and provide further reasons for potential partners to speak to us."
"We have always stated that we are a science-led company, therefore the larger moisturisation clinical trial that is due to commence later this month will be of key importance to us. We expect this data will demonstrate the longer term effects of our technology (>24 hours) and the results will play a key part in the talks with commercial partners.”